FDA leans on detention powers in USPLabs, GNC DMAA debacle

The Bioterrorism Act of 2002 granted the U.S. Food and Drug Administration (FDA) authority to temporarily detain foods (including dietary supplements) without a judge's order. But FDA has explained it needed "credible evidence or information that the food presented a threat of serious adverse health consequences or death to humans or animals."

Signed into law by President Obama in early 2011, the FDA Food Safety Modernization Act (FSMA) lightened the burden on the agency. FDA officials now can detain food if they "have a reason to believe" that a substance "is adulterated or misbranded." Those terms are defined under the Federal Food, Drug and Cosmetic Act (FD&C).

In spite of the new criteria, the agency has used its detention powers sparingly.

Jennifer Thomas, FDA's director of the Division of Enforcement in the Office of Compliance, said the agency has used its authority to detain food on six occasions. Three of the detentions have not been made public.

In the fall of 2011, FDA detained food products for the first time, following an inspection of a facility that revealed evidence of a rodent and insect infestation. FDA investigators found rodent droppings and urine stains on or around food products, a dead rodent in the warehouse, and live and dead insects on and in the vicinity of food.

About four months later, FDA ordered the detention of a cold-smoked salmon product after inspectors found Listeria monocytogenes within a firm's facility and on processing equipment.

In the most recent case that has been publicized, FDA detained supplements containing an amphetamine derivative (1, 3-dimethylamylamine or DMAA) that has been linked to deaths and serious illnesses. The government agency tagged the weight-loss and muscle building products, prohibiting them from leaving the warehouses of GNC Holdings, Inc., and USPlabs, the Dallas-based manufacturer of the OxyElite Pro and Jack3d supplements.

In April 2012, FDA warned USPlabs that DMAA was adulterated. DMAA, the agency declared, was a "new dietary ingredient" whose history of use or other evidence did not establish that it was reasonably "expected to be safe".

In spite of the warning letter, USPlabs continued to market the supplements because it maintained DMAA was not dangerous. In a consumer advisory one year later, FDA disclosed receiving 86 reports of illnesses and death associated with DMAA. FDA declared the stimulant could heighten blood pressure and lead to such cardiovascular problems as shortness of breath, tightening of the chest and a heart attack.

The message was plain: government deemed DMAA to be a dangerous substance.  Days later, USPlabs announced plans to remove the stimulant from its products even though it strongly disagreed with FDA's position.

USPlabs and the supplement retailer GNC didn't immediately destroy the remaining inventory of the DMAA products. In an email on May 9, a spokesperson for GNC reiterated a previous statement that "pending a recall order on the products from the FDA, GNC will continue selling what inventory we have left of the USPlabs product."

A month later, FDA intervened, detaining OxyElite Pro and Jack3d in GNC's warehouses in Pennsylvania. USPlabs' products also were detained in Texas.

But the agency only has authority under FSMA to detain food for up to 30 days. On behalf of FDA, the U.S. Department of Justice filed complaints in three federal courts, requesting orders to seize and forfeit the products that contained DMAA.

Finding "probable cause" that OxyElite Pro and Jack3d were adulterated under the FD&C, the courts in Arizona, Pennsylvania and South Carolina ordered U.S. marshals to seize the supplements.

All three cases were dismissed after USPlabs and GNC agreed to destroy the products. According to FDA officials, the total inventory of DMAA destroyed at the GNC and the USPlabs facilities had a retail value of roughly $8.5 million.

"When FDA finds an adulterated or misbranded food product, FDA will consider use of administrative detention to help protect consumers," Thomas, the FDA official, stated in an email.

FDA didn't detain the products until 14 months after sending USPlabs a warning letter. Thomas explained the agency had to thoroughly review information that the company provided in response to the letter.

"We needed to fully consider the information before we took additional action," she said.

USPlabs and GNC had the right to appeal the administrative detentions before FDA and argue their case in an informal hearing under the agency's rules. Such a hearing is held within two calendar days after an appeal is filed. The companies also could have fought the court actions filed by the Justice Department.

Instead, they capitulated to FDA's demands.

USPlabs didn't respond to a request for comment for this article. Laura Brophy, a spokeswoman with GNC, said the manufacturer of the products, USPlabs, "was the appropriate party to appeal the FDA's actions."

"The FDA has always had the regulatory power to order a recall of any dietary supplement product or ingredient it declares to be unsafe, but chose not to exercise that power with DMAA products," she said in an email.

It was America's increased vigilance in the wake of the Sept. 11, 2011, terrorist attacks that gave birth to FDA's initial detention powers.

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) amended the FD&C, providing FDA authority to detain food if an "officer or qualified employee" found "credible evidence or information indicating that such article [of food] presents a threat of serious adverse health consequences or death to humans or animals."

The final regulations carrying out FDA's detention authority were adopted in 2004. But FDA never used its powers under the Bioterrorism Act to detain food. Ricardo Carvajal, an attorney with Hyman, Phelps & McNamara in Washington, D.C. and former associate chief counsel in FDA's Office of Chief Counsel, has attributed FDA's restraint to the more stringent standard that applied to administrative detention "coupled with the fact that foods meeting this standard are typically the subject of Class 1 voluntary recalls or are embargoed by the states".

FDA's interim final rule under FSMA's new criteria took effect on July 3, 2011. (The final rule was announced earlier this year; it made no changes to the previous version).

In the rule, the agency has acknowledged it is more likely to  detain food "where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."

On July 23, in the U.S. District Court for the Western District of Pennsylvania, prosecutors moved to dismiss the case that sought disposal of USPlabs' dietary supplements in GNC's Leetsdale, Penn., warehouse.

After the complaint had been filed, GNC reached out to FDA and offered to destroy the products, Assistant U.S. Attorney David Lew wrote in the notice of voluntary dismissal. An FDA representative was present when the products were destroyed on July 9-10, he said.

Only a few weeks after the dismissal notice was filed, the Department of Defense released a report that concluded DMAA did not cause the deaths of four soldiers.

"It was the opinion of the AFMES [Armed Forces Medical Examiner Service] that DMAA did not play a significant role in the deaths of these four Service members," the report, which constituted the findings of a safety review panel convened by the military, stated.

The panel found use of supplements containing DMAA "appears to convey low risk of serious harm for most healthy Service-members at the doses recommended by the manufacturer." Still, the deaths and other adverse events such as seizure and stroke associated with service members' use of the stimulant "suggest that some individuals may be predisposed to severe health consequences after using DMAA," the report stated.

GNC believes its position in defense of DMAA has been vindicated.

"We are delighted that a nearly two-year review by the military of DMAA products validated what we already knew; namely, that products containing DMAA do not cause adverse medical events," Brophy, the GNC spokeswoman said. "This is a perfect example of how unjustified criticism of dietary supplements is simply not supported by sound science."

But Daniel Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Programs, has characterized the destruction of the supplements containing DMAA as a "victory for consumers".

"FDA has received reports of more than 100 illnesses associated with products containing DMAA, including six deaths," he wrote in a blog July 30.